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NCT02437344 · ClinicalTrials.gov registry record · Phase 2
Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT02437344 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 16 participants.
The verdict
NCT02437344, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
Opioid dependence is a substantial problem associated with significant morbidity and mortality. Extended-release naltrexone has been found effective at reducing opioid use and maintaining abstinence, but its use has been limited by the difficulties encountered with treatment initiation, which involves detoxification from opioids and oral naltrexone titration. Improving the likelihood of a successful transition to naltrexone is therefore an important public health goal. N-methyl-D-aspartate receptor (NMDA) antagonism has been found to alleviate the signs and symptoms of withdrawal from opioids, as well as to address adaptations associated with chronic opioid use, such as opioid-induced hyperalgesia (increased pain sensitivity). These benefits may persist for at least 72 hours after a single dose. NMDA antagonism may therefore facilitate a rapid transition to naltrexone by reducing discomfort, improving motivation, and ameliorating adaptations associated with drug dependence, such as craving and arousal. The purpose of this trial is to assess the feasibility of NMDA antagonist-assisted naltrexone initiation in opioid dependent individuals. After administration of extended-release naltrexone, participants will be followed for 4 weeks, and transitioned to appropriate care subsequently (oral naltrexone, extended-release naltrexone).
Interventions
- DRUG CI-581aa
- DRUG Naltrexone titration and XR-NTX initiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02437344
The ClinicalTrials.gov registry entry for NCT02437344 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CI-581aa is the first listed.
NCT02437344 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02437344 about?
NCT02437344 is a clinical study titled "Glutamatergic Modulation to Facilitate Naltrexone Initiation in Opioid Dependence". Opioid dependence is a substantial problem associated with significant morbidity and mortality. Extended-release naltrexone has been found effective at reducing opioid use and maintaining abstinence, but its use has been limited by the difficulties encountered with treatment initiation, which involv...
What is the current status of trial NCT02437344?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2015-01. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02437344?
The interventions under investigation include: CI-581aa (DRUG), Naltrexone titration and XR-NTX initiation (DRUG).
Who is sponsoring clinical trial NCT02437344?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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